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肝转移瘤的电凝治疗

Electro-coagulation for liver metastases.

作者信息

Riemsma Robert P, Bala Malgorzata M, Wolff Robert, Kleijnen Jos

机构信息

Kleijnen Systematic Reviews Ltd, York, UK.

出版信息

Cochrane Database Syst Rev. 2013 May 31(5):CD009497. doi: 10.1002/14651858.CD009497.pub2.

Abstract

BACKGROUND

Primary liver tumours and liver metastases from colorectal carcinoma are the two most common malignant tumours to affect the liver. The liver is second only to the lymph nodes as the most common site for metastatic disease. More than half of the patients with metastatic liver disease will die from metastatic complications. Electro-coagulation is the coagulation (clotting) of tissue using a high-frequency electrical current applied locally with a metal instrument or needle with the aim of stopping bleeding. The object of this technique is to destroy the tumour completely, if possible, in a single surgical session.

OBJECTIVES

To study the beneficial and harmful effects of electro-coagulation compared with no intervention, to other ablation methods, or systemic treatments in patients with liver metastases.

SEARCH METHODS

We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, LILACS, and CINAHL up to December 2012.

SELECTION CRITERIA

We included one randomised clinical trial that assessed beneficial and harmful effects of electro-coagulation and its comparators in patients with liver metastases, irrespective of the location of the primary tumour.

DATA COLLECTION AND ANALYSIS

We extracted relevant information on participant characteristics, interventions, study outcome measures, and data on the outcome measures as well as information on the design and methodology of the trials. Risk of bias of the trials and data extraction was carried out by one author and checked by a second author.

MAIN RESULTS

We included one randomised clinical trial that compared four groups: electro-coagulation alone, electro-coagulation + dimethyl sulphoxide, electro-coagulation + allopurinol, and control (Salim 1993). The risk of bias in the trial is high. In three groups, patients had their metastases destroyed with diathermy electro-coagulation (current set at No 5) and received: 1) solution of allopurinol by mouth 5 mL 4 x a day or 2) allopurinol by mouth 5 mL (50 mg) 4 x a day or 3) dimethyl sulphoxide by mouth 5 mL (500 mg) 4 x a day. In the control group patients received a solution of allopurinol by mouth 5 mL 4 x a day. The treatment was started in the fifth postoperative day and was continued for five years. Three hundred and six patients who had undergone resection of the sigmoid colon and who had five or more hepatic metastases were included; 75 received electro-coagulation alone (58 were evaluable), 76 received electro-coagulation plus allopurinol (53 were evaluable), 78 received electro-coagulation plus dimethyl sulphoxide (57 were evaluable), and 77 were in the control group (55 evaluable).The authors reported the number of deaths due to disease spread (100% in the control, 98% in electro-coagulation, 87% in electro-coagulation + allopurinol, and 86% in the electro-coagulation + dimethyl sulphoxide groups). There was a significant benefit in favour of the electro-coagulation + allopurinol (risk ratio (RR) 0.87 (95% confidence interval (CI) 0.78 to 0.96)) and electro-coagulation + dimethyl sulphoxide (RR 0.86 (95% CI 0.77 to 0.95)) groups compared to the control group, but no such benefit in the electro-coagulation alone group (RR 0.98 (95% CI 0.95 to 1.02)) compared to the control group. There were no local recurrences, no positive tests for occult blood, and observed pulmonary metastases were always with ultrasonographic evidence of hepatic secondaries and were not significantly different for the experimental groups compared to the control group (electro-coagulation: RR 1.11 (95% CI 0.4 to 3.09)), electro-coagulation + allopurinol (RR 0.86 (95% CI 0.28 to 2.66)), electro-coagulation + dimethyl sulphoxide (RR 0.8 (95% CI 0.26 to 2.48)). None of the adverse events were significantly associated with treatment.

AUTHORS' CONCLUSIONS: On the basis of one randomised trial which did not describe its methodology in sufficient detail to assess risk of bias and quality, excluded 27% of patients after randomisation due to various reasons, and is probably not free from selective outcome reporting bias, there is insufficient evidence to conclude that in patients with colonic cancer liver metastases, electro-coagulation alone brings any significant benefit in terms of survival or recurrence compared with the control. In addition, there is insufficient evidence for the effectiveness of adding allopurinol or dimethyl sulphoxide to electro-coagulation. The probability for selective outcome reporting bias in the trial is high. More randomised trials are needed in order to sufficiently validate electro-coagulation with or without co-interventions.

摘要

背景

原发性肝癌和结直肠癌肝转移是影响肝脏的两种最常见的恶性肿瘤。肝脏是继淋巴结之后最常见的转移疾病部位。超过一半的肝转移患者将死于转移并发症。电凝是使用高频电流通过金属器械或针在局部施加,使组织凝固(凝血)以达到止血目的。该技术的目标是在可能的情况下,在单次手术中完全摧毁肿瘤。

目的

研究与不干预、其他消融方法或全身治疗相比,电凝对肝转移患者的有益和有害影响。

检索方法

我们检索了Cochrane肝胆组对照试验注册库、Cochrane图书馆中的Cochrane对照试验中央注册库(CENTRAL)、MEDLINE、EMBASE、科学引文索引扩展版、LILACS和CINAHL,检索截至2012年12月的文献。

选择标准

我们纳入了一项随机临床试验,该试验评估了电凝及其对照措施对肝转移患者的有益和有害影响,无论原发肿瘤的位置如何。

数据收集与分析

我们提取了有关参与者特征、干预措施、研究结局指标以及结局指标数据的相关信息,以及试验设计和方法的信息。试验的偏倚风险和数据提取由一位作者进行,另一位作者进行核对。

主要结果

我们纳入了一项随机临床试验,该试验比较了四组:单纯电凝、电凝+二甲基亚砜、电凝+别嘌醇和对照组(Salim 1993)。该试验的偏倚风险较高。在三组中,患者通过透热电凝(电流设置为5档)破坏转移灶,并接受:1)口服别嘌醇溶液5 mL,每日4次;或2)口服别嘌醇5 mL(50 mg),每日4次;或3)口服二甲基亚砜5 mL(500 mg),每日4次。对照组患者口服别嘌醇溶液5 mL,每日4次。治疗在术后第5天开始,持续5年。纳入了306例接受乙状结肠切除术且有5个或更多肝转移灶的患者;75例接受单纯电凝(58例可评估),76例接受电凝加别嘌醇(53例可评估),78例接受电凝加二甲基亚砜(57例可评估),77例为对照组(55例可评估)。作者报告了因疾病扩散导致的死亡人数(对照组为100%,电凝组为98%,电凝+别嘌醇组为87%,电凝+二甲基亚砜组为86%)。与对照组相比,电凝+别嘌醇组(风险比(RR)0.87(95%置信区间(CI)0.78至0.96))和电凝+二甲基亚砜组(RR 0.86(95%CI 0.77至0.95))有显著益处,但单纯电凝组与对照组相比无此益处(RR 0.98(95%CI 0.95至1.02))。没有局部复发,隐血试验均为阴性,观察到的肺转移总是伴有肝脏转移的超声证据,与对照组相比,实验组无显著差异(电凝组:RR 1.11(95%CI 0.4至3.09)),电凝+别嘌醇组(RR 0.86(95%CI 0.28至2.66)),电凝+二甲基亚砜组(RR 0.8(95%CI 0.26至2.48))。没有不良事件与治疗有显著关联。

作者结论

基于一项随机试验,该试验未充分详细描述其方法以评估偏倚风险和质量,随机分组后因各种原因排除了27%的患者,且可能存在选择性结局报告偏倚,因此没有足够的证据得出结论,在结肠癌肝转移患者中,与对照组相比,单纯电凝在生存或复发方面没有带来任何显著益处。此外,没有足够的证据证明在电凝基础上加用别嘌醇或二甲基亚砜的有效性。该试验存在选择性结局报告偏倚的可能性较高。需要更多的随机试验来充分验证电凝联合或不联合辅助干预措施的效果。

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